FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04037691773513
·
Model: HLS Set Advanced 5.0, Small Adult, BIOLINE Coating
·
Maquet Cardiopulmonary AG
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04037691773513
- Version / Model
- HLS Set Advanced 5.0, Small Adult, BIOLINE Coating
- Catalog Number
- 70105.2797
- Company Name
- Maquet Cardiopulmonary AG
- Labeler DUNS
- 316153865
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-12
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 0ea7178d-f058-4bca-81f2-2ee5e10032a5
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4350 | 2 |
| DTR | HEAT-EXCHANGER, CARDIOPULMONARY BYPASS | Cardiovascular | 870.4240 | 2 |
| KFM | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | Cardiovascular | 870.4360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35441 | Cardiopulmonary bypass system blood tubing set | A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04037691773513 | GS1 |
Customer Contacts
- Phone
- +49072229320
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112360 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Connection size 1/4 Inch | ||
| Total Volume | 570 | Milliliter |